The Court of Appeal of Aix-en-Provence confirmed on Wednesday the indictments of the French subsidiary of the German pharmaceutical company Merck and the French Medicines Agency, for «deception», in 2022, in the case of the change in formula of the drug Levothyrox.
The indictments of the French subsidiary of the German pharmaceutical company Merck and the French Medicines Agency in the case of the change in formula of the drug Levothyrox were confirmed on Wednesday by the Court of Appeal of Aix-en-Provence. The judicial investigation into the criminal aspect of the case is still ongoing and no trial date has been set.
In France, nearly three million people use a product based on levothyroxine for the treatment of thyroid disorders. The case has led to several legal actions since 2017. France 3 Provence-Alpes revisits this case in eight acts, pitting thousands of patients against the manufacturer.
Act 1: a new formula is introduced to the market
The case begins in late March 2017. At the request of the National Agency for the Safety of Medicines (ANSM), a new formula of Levothyrox is introduced to the French market. This treatment is used daily by nearly three million French people, treated for thyroid disorders.
The new composition of Levothyrox includes the same active ingredient, levothyroxine, but with new excipients, in order to make its composition more stable, and therefore more effective.
Act 2: thousands of patients report side effects
Headaches, dizziness, insomnia, cramps, extreme fatigue, digestive problems, hair loss… quickly, patients complain of side effects, which they attribute to the new formula. «Letting this situation continue is senseless and dangerous: some people stop their treatment. I also thought about it, but of course you must not do that because this medication is vital. So I hope that our alarm call will be heard very soon,» testifies actress Anny Duperey in Le Parisien.
By the end of June 2017, a petition calling for the return of the original formula was launched, gathering over 200,000 signatures.
Act 3: The old formula returns to pharmacies
On October 2, 2017, the old formula of Levothyrox returns to pharmacies under the name Euthyrox.
The treatment is «prescribed only as a last resort to patients, in limited numbers, who experience lasting side effects with other specialties,» specifies the ANSM.
The distribution of the old formula under the name Euthyrox, which was supposed to stop in 2020, has been extended several times since then, including for 2024 and 2025.
Act 4: a criminal investigation is opened in Marseille
On March 2, 2018, a criminal investigation against X is opened for «aggravated deception, involuntary injury, and endangering others.» It is entrusted to a judge from the public health pole of the TGI of Marseille, whose jurisdiction extends to Lyon, where the German laboratory is based.
Seven thousand complaints are then recorded in France, according to the public prosecutor Xavier Tarabeux. In total, 17,000 patients reported adverse effects after the new formula of Levothyrox was introduced to the market.
Act 5: ANSM concludes that the new formula does not cause «serious problems»
On June 13, 2019, the ANSM reveals the final report of a pharmaco-epidemiological study conducted on over two million patients using data from the National Health Data System (SNDS) by the Scientific Interest Group EPI-PHARE.
According to the ANSM, «this study does not show an increase in the occurrence of serious health problems (…) related to the switch to the new formula of Levothyrox in France.»
«These results do not provide arguments in favor of a specific toxicity of the new formula of Levothyrox. They rather reflect the difficulties encountered by some patients during the formula change, as reported through notifications to the pharmacovigilance system or in public statements of patients, particularly regarding the lack of information on the formula change,» it concludes.
Act 6: Merck ordered to compensate over 3,000 patients
In the civil aspect, the pharmaceutical group is convicted, on June 25, 2020, by the Court of Appeal of Lyon for «fault» at the time of the formula change. The laboratory is ordered to pay 1,000 euros to each of the plaintiffs «for moral prejudice,» as part of a collective complaint for «failure to inform» and «emotional distress.»
The company considers the decision «totally incomprehensible» and appeals to the Court of Cassation. In March 2022, the Court of Cassation rejects Merck’s appeal, which must compensate 3,329 users (about 800 have dropped out of the process) who suffered from side effects following the formula change. In the first instance, in March 2019, the plaintiffs were dismissed by the Lyon District Court, which handled the civil aspect of the case.
They were demanding 10,000 euros in compensation each, totaling 33 million euros.
According to Merck, around 2.5 million patients are using the new formula of Levothyrox, compared to «less than 100,000» people taking the old formula imported under the name Euthyrox. Five alternative medications based on levothyroxine are also available in the French market.
Act 7: Merck’s subsidiary and ANSM are indicted for «deception»
On November 16, 2022, the French subsidiary of the German pharmaceutical company Merck was indicted for «aggravated deception.» A month and a half later, on December 5, ANSM was also prosecuted in the same case for «deception.»
«ANSM has never denied the difficulties faced by some patients when transitioning to the new formula of Levothyrox and is constantly and actively concerned about the safety and health of patients,» the drug agency responded in a statement.
Act 8: The indictments are confirmed by the court
«The chamber of instruction (…) has, in accordance with the general prosecutor’s requisitions, rejected the three requests for annulment of their respective indictments filed by the counsels of the companies Merck Serono, Merck Santé (the two entities responsible for the development and distribution of Levothyrox) and ANSM,» according to three judgments rendered on Wednesday.
«We regret this decision and firmly maintain that Merck has not committed any offense. Neither the quality of the medication nor the information provided to patients during the transition from the old to the new formula of Levothyrox can be attributed to the companies of the Merck group in France,» Merck responded in a statement sent to AFP. The group specified that it will appeal to the Supreme Court.
La filiale française du laboratoire pharmaceutique allemand Merck a été confiée à un juge du pôle de santé publique du TGI de Marseille, dont la compétence s’étend jusqu’à Lyon, où siège le laboratoire allemand. 17 000 patients ont signalé des effets indésirables après la mise sur le marché de la nouvelle formule du Levothyrox, selon le procureur de la république Xavier Tarabeux.
L’ANSM a conclu que la nouvelle formule n’engendre pas de «problèmes graves» après une étude de pharmaco-épidémiologie menée sur plus de deux millions de patients. Merck a été condamné à indemniser plus de 3 000 patients pour «faute» au moment du changement de formule. En première instance, les plaignants avaient été déboutés, mais en appel, Merck a été condamné à verser 1 000 euros à chacun des plaignants pour «défaut d’information» et «préjudice d’angoisse».
En mars 2022, la Cour de cassation a confirmé que Merck doit indemniser 3 329 utilisateurs ayant souffert d’effets secondaires. En parallèle, la filiale de Merck et l’ANSM ont été mis en examen pour «tromperie aggravée». La justice a confirmé les mises en examen, malgré les contestations de Merck qui maintient que le groupe n’a commis aucune infraction.
En décembre 2022, l’ANSM a également été poursuivie pour «tromperie» dans le même dossier. Les mises en examen des deux entités ont été confirmées par la cour d’appel d’Aix-en-Provence. Merck a annoncé son intention de se pourvoir en cassation. La situation demeure complexe et controversée, avec des enjeux importants en matière de santé publique et de responsabilité des acteurs pharmaceutiques. The criminal investigation in the case is still ongoing and no trial date has been set.
In France, nearly three million people use a product containing levothyroxine for thyroid disorders. The case has led to several legal actions since 2017. France 3 Provence-Alpes revisits the story in eight acts, detailing the conflict between thousands of patients and the manufacturer.
Act 1: A new formula is introduced to the market in late March 2017. At the request of the National Agency for the Safety of Medicines (ANSM), a new formula of Levothyrox is released in France. This treatment is used daily by nearly three million French people treated for thyroid disorders.
The new composition of Levothyrox includes the same active ingredient, levothyroxine, but with new excipients to make the composition more stable and therefore more effective.
Act 2: Thousands of patients report experiencing side effects such as headaches, dizziness, insomnia, cramps, extreme fatigue, digestive issues, and hair loss from the new formula. A petition demanding the return of the original formula quickly garners over 200,000 signatures.
Act 3: The old formula returns to pharmacies under the name Euthyrox on October 2, 2017, prescribed only as a last resort to patients experiencing lasting adverse effects with other options.
Act 4: A criminal investigation is opened in Marseille on March 2, 2018, for «aggravated deception, involuntary injury, and endangering others». Thousands of complaints are filed, with a total of 17,000 patients reporting adverse effects after the introduction of the new Levothyrox formula.
Act 5: The ANSM concludes that the new formula does not cause «serious health problems» based on a pharmaco-epidemiological study involving over two million patients.
Act 6: Merck is ordered to compensate over 3,000 patients for the changes in the Levothyrox formula, with the company appealing the decision but ultimately being required to pay indemnities to affected users.
Act 7: Both Merck’s subsidiary and the ANSM are indicted for «deception» in the case.
Act 8: The indictments are confirmed by the justice system, with Merck maintaining its innocence and planning to appeal the decision. Rewrite the sentence to make it clearer:
«I didn’t understand what you meant by that.»
«I am confused about your statement and need clarification.»
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